Associate Director, Regulatory Affairs – ATMP’s/CAR-T Products. Development and Life-cycle management in Oncology

Associate Director, Regulatory Affairs – ATMP’s/CAR-T Products. Development and Life-cycle management in Oncology.

Drug Development, Registrations/New indications, and Life-cycle Management for a fast-growing Biotech in two locations!! This is an outstanding opportunity for a seasoned Life-cycle management expert who wishes to move into ATMP’s from General Biopharma.

Drug Development and Strategy, but additional experience in in Regulatory Life-cycle management is crucial – ATMP/CAR-T Product experience is welcomed, but not necessarily essential, hence if your background is Life-cycle management in Biopharma Products this role could not only be a good fit, but also an opportunity to enter a ‘Cutting-edge’ Product area.

CTA’s PIP’s ODD’s, Leading Scientific Advice meetings; New indications, Life-cycle Management – Line Extensions and complex Variations.

Are you already a Senior Manager or already an Associate Director, ready to take the step-up to ATMP’s? If so, this is the opportunity you have been waiting for. This Associate Director, Regulatory Affairs Oncology Cell Therapy position is for a fast-growing Biotech; this organisation has a successful established product portfolio and expanding into new Therapeutic areas. The Product range is impressive.

You will be adept in operating within Multi-functional Teams and in a Matrix-environment.

Reporting to the Director – GRL, you will be required Project Lead and Manage with ‘dotted-line’ reports hence previous Project Leading and mentoring is required. You will be responsible for the implementation of European Regulatory Strategy within a Global context. You will maintain the organisation’s existing product licences, and to integrate newly approved products into the portfolio. Management of overseas Affiliates and other Partners. Liaison with appropriate Regulatory Authorities, particularly the EMA.

Technically, you will have good working knowledge and experience of Development, Registrations and Post marketing activity: Life-cycle management; CTD/Dossiers for MAA’s (ideally, all Modules 1 to 5); National Submissions/MRP, DCP and particularly – Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL’s and SmPC’s. Your geographic scope will be Pan- European and possibly some international territories.

CTA’s PIP’s ODD’s, Leading Scientific Advice meetings; Life-cycle Management – Line Extensions and complex Variations.

Candidates from a Biologics background in European & International Regulatory Life-cycle management with over 8 years’ experience, and good mentoring skills should be suitable for this position.

ATMP experience is ideal, but candidates from a strong Biologics background are invited to apply.

You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.

There is a choice of two locations, and flexible working is permitted – 2/3 days per week for home.

If you are interested in this, or any other Regulatory Affairs roles, please contact Julian Turner at Turner Regulatory Recruitment on 0203 695 9477/07447 977 330 or by julian@turnerregulatory.com

 

Some Of Our Feedback

  • A fast-growing Biotech Company were struggling to find a Vice President, Global Regulatory Affairs and having engaged a major Executive Search firm in the USA had spent over 1 year looking for the right candidate without success. Within 8 weeks of requesting my help, we provided the company with 12 candidates, from which the ideal candidate was selected, who, over two years on, is still successfully operating within this role.

  • A leading Biopharma Company were looking for an Associate Director, Regulatory Strategy Team Lead for Emerging Markets, but had thus far failed to secure the right candidate. In fact, after 6 months of trying they’d only been able to secure an interview with one, less than ideal, candidate. Within 30 days of working with myself, a very suitable candidate was identified and started working for the company within 3 months. We provided the Biopharma Company with 11 excellent candidates to choose from.

  • A Pharmaceutical Company contacted me to find their new Head of Regulatory Affairs, to be based in a challenging location. Within 60 days of approaching me, after an intercontinental recruitment campaign, 6 candidates were identified and delivered. A suitable candidate was chosen and placed. The Company expressed their gratitude for having exceeded their expectations.

  • A newly created Vaccines organisation tasked Turner Regulatory Recruitment with finding a Head of Region, Senior Director, EU Regulatory Affairs. At the time, there were a number of Biotech/Vaccines companies seeking to fill similar positions; however, in spite of these challenging market conditions 13 candidates were identified and put forward from the ensuing short-listing process, one particular candidate was chosen, offered and accepted; this candidate is still happily in situ.

  • A well-established and commercially successful Biotech Company was having trouble in sourcing a Senior Director Regulatory CMC with a European/EMEA focus for their London Office. This organisation had been seeking to fill this role using numerous Agencies/Head-hunters for well over 6 months without success. Turner Regulatory Recruitment took a fresh and targeted approach to the role, identifying and delivering 8 excellent candidates. From the following interviewing process, not 1, but 2 candidates were offered, and both accepted.